Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury

Cirrhosis, Liver Clinical Trial

Official title:

Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05434286
• Other study ID #: IM-2020-2145
• Status: Active, not recruiting
• Start date: December 15, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: April 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately.

We will assess IVC dynamics, LV systolic function [LV ejection fraction (EF) & cardiac output (CO)], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: June 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Cirrhosis of any Etiology

• Patient with acute kidney injury meeting HRS-AKI criteria

Exclusion Criteria:

• Hepatocellular carcinoma

• Patients with active variceal bleeding

• HIV or severe immunocompromised state

• Chronic kidney disease (CKD) on renal replacement therapy (RRT),

• Previous transjugular intra hepatic portosystemic shunt (TIPS)

• Porto-pulmonary hypertension,

• Coronary artery disease

• Congenital or valvular heart disease

• Prosthetic cardiac valves

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute-On-Chronic Liver Failure
• AKI
• Ascites
• Cirrhosis, Liver
• End Stage Liver Disease
• Fibrosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Liver Failure
• Refractory Ascites
• Syndrome

Intervention

Diagnostic Test:
• Echocardiographic assessment
POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin and terlipressin

Locations

Country	Name	City	State
India	PGIMER	Chandigarh	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

Adebayo D, Neong SF, Wong F. Refractory Ascites in Liver Cirrhosis. Am J Gastroenterol. 2019 Jan;114(1):40-47. doi: 10.1038/s41395-018-0185-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output measurement by echocardiography	Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0 and 48 hours after enrollment.; The cardiac output at 7 days after enrollment will also be documented. he Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation.; Cardiac output(CO), Stroke volume (SV), Heart rate (HR); CO = [SV * HR]/ 1000	Day 0, Day 2, Day 7.
Primary	IVC size and collapsibility changes	IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.	Day 0.
Primary	IVC size and collapsibility changes	IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.	Day 2
Primary	IVC size and collapsibility changes	IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded.	Day 7.
Primary	Number of patients with Complete Response in HRS-AKI	Complete response is defined as a reversal in AKI with a final serum Creatinine (sCr) value of = 0.3 mg/dL of the baseline.	Day 7
Primary	Number of patients with Partial Response in HRS-AKI	Partial response is defined as regression in the stage of AKI with a final sCr > 0.3 mg/dL above the baseline.	Day 7
Primary	Number of patients with Non-Response in HRS-AKI	Non-responder is defined if the sCr did not decrease or increased from the baseline.	Day 7
Secondary	Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level		Day 0 and Day 7
Secondary	Change in NT Pro brain natriuretic peptide (BNP) level		Day 0 and Day 7
Secondary	Change in plasma renin activity level		Day 0 and Day 7
Secondary	Change in Galectin-3 level		Day 0 and Day 7